Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy (FMTB Brij)

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Gender Dysphoria; Mastectomy; Hypertrophic Scar

Treatments: Device: Brijjit® BP100-6 and BP-75; Other: Control: Standard of care and normal wound dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT07147166

24-43094

Details and patient eligibility

About

The goal of this randomized, prospective, interventional clinical trial is to evaluate the use of Brijjit® in reducing the incidence of hypertrophic scarring in individuals undergoing gender-affirming bilateral double incision mastectomies at a single-institution, single-surgeon site (Esther A. Kim, MD). Patients will serve as a self-control (one side of the chest receives intervention, the other serves as a control). Primary endpoints include scar appearance and quality. Secondary endpoints include patient perception of the scar using the Patient and Observer Scar Assessment Scale (POSAS).

Participants will be taught how to apply Brijjit® at home if any units fall off before 6 weeks postop.

Full description

The hypothesis of this study is that the use of Brijjit® Force-Modulating Tissue Bridge devices will reduce the incidence of hypertrophic scarring as measured by objective and subjective factors compared to no intervention following gender-affirming double incision mastectomy. Patients will serve as self-controls (one side of the chest will receive the intervention, the other will not). Consistent use of silicone-based tape, the current gold standard for wound care, will be encouraged on the control side of the chest.

We hypothesize that applying FMTBs to surgical incisions will improve scar outcomes by limiting pro-fibrotic signaling and promoting optimal wound healing. Should our hypotheses be proven, this study will provide a compelling reason to implement Brijjit therapy into standard clinical practice as a non-invasive preventative measure to improve scar outcomes.

Enrollment: 78 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age ≥ 19
2. Undergoing double incision gender affirming mastectomy
3. Ability to adhere to Brijjit therapy after surgery
4. Willing to return for follow-up visits and undergo study evaluations

Exclusion criteria

1. History of keloid formation
2. Radiation therapy history
3. Prior surgeries of the chest or breast
4. History or use following prescription medications: 1) accutane within the past year. 2) chronic systemic steroids
5. Active smoker
6. Disorder known to negatively affect wound healing (autoimmune, connective tissue, uncontrolled diabetes)
7. Any other condition determined by PI to preclude subject from joining study

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Self-control Brijjit Application and Control

Experimental group

Description:

The side of the chest that the Brijjit is applied to will be randomly allocated using a web-based, open-source randomizer. Initial application will be done intraoperatively, following final skin closure. Brijjit will be applied across the entire incision length. Following application, Brijjit has been shown to last for 2-4 weeks. Patients will remain in a chest vest binder with dressings until the initial follow-up visit at 2 weeks. At this follow up visit, any Brijjit that has fallen off will be replaced. Patients will be taught how to reapply Brijjit if it falls off, and they will be instructed to continue Brijjit therapy until 6 weeks post-op. Any remaining Brijjit devices will be removed at the 6 week post-op visit. At this time, patients will be able to initiate recommended scar care to both chest sides. The control chest side will receive only standard of care and normal wound dressing.

Treatment:

Other: Control: Standard of care and normal wound dressing

Device: Brijjit® BP100-6 and BP-75